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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
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Title of Standard
 
 
08/02/2011 Anesthesiology 1-85 ISO 80601-2-61 First edition 2011-04-01 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
06/07/2018 Anesthesiology 1-133 ISO 10079-3 Third Edition 2014-05-01 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
08/14/2015 Anesthesiology 1-105 ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment -- Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
08/20/2012 Anesthesiology 1-87 IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
01/30/2014 Anesthesiology 1-78 ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human Occupancy
01/14/2019 Anesthesiology 1-141 ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
08/14/2015 Anesthesiology 1-104 ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015)]
04/04/2016 Anesthesiology 1-115 ISO 80601-2-70 First Edition 2015-01-15 Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment
03/16/2012 Anesthesiology 1-72 ANSI AAMI ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
06/07/2018 Anesthesiology 1-132 ISO 10079-2 Third Edition 2014-05-01 Medical suction equipment - Part 2: Manually powered suction equipment
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